title: The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy.
abstract: OBJECTIVE
  Ambulatory blood pressure monitoring (ABPM) has greater predictive value than office blood pressure (BP) with respect to hypertension-related target-organ damage and morbidity. ABPM in a subset of 80 patients from the Exforge Target Achievement trial (N=728) was used to compare the efficacy of intensive-treatment and moderate-treatment regimens of amlodipine/valsartan, and to determine whether treatment differences could be better assessed with ABPM than with office or home BP. Home BP was measured on the morning of clinic visits to minimize differences that timing might have on home versus office BP measures.
  
  
  METHODS
  A 12-week randomized, double-blind study in which hypertensive patients earlier uncontrolled (mean sitting systolic BP≥150 and <200 mmHg) on angiotensin receptor blocker monotherapy (other than valsartan) after 28 days or more (N=728) were randomized to amlodipine/valsartan treatment [10/320 mg (intensive) or 5/160 mg (moderate)]. Treatment-naive patients (in previous 28 days) or patients who failed on a nonangiotensin receptor blocker agent underwent a 28-day run-in period with a 20-mg or 40-mg dose of olmesartan, respectively.
  
  
  RESULTS
  Significantly greater 24-h ABP reductions from baseline to week 4 (primary time point) were observed with intensive versus moderate treatment (least-square mean systolic/diastolic BP reduction of -16.2/-10.1 vs. -9.5/-6.5 mmHg; P=0.0024/P=0.010 for least-square mean difference). Similarly, a significantly greater proportion of patients receiving an intensive treatment achieved ambulatory BP goal (<130/80 mmHg) at week 4 than did those receiving a moderate treatment (P=0.040). Treatment-group differences did not reach statistical significance for these end points when measured by office and home BP.
  
  
  CONCLUSIONS
  In this first randomized trial evaluating the effects of intensive versus moderate dosing of the combination of amlodipine/valsartan, our data suggest that ABPM was a better method for assessing between-treatment differences than clinic or home BP recordings, although measurement of home BP as a single recording was a limitation of our trial.
authors.affiliation: Tulane University School of Medicine, New Orleans, Louisiana, USA. tgiles4@cox.net
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Giles
authors.forename: Suzanne
authors.initials: S
authors.lastname: Oparil
authors.forename: Elizabeth O
authors.initials: EO
authors.lastname: Ofili
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.forename: Das
authors.initials: D
authors.lastname: Purkayastha
authors.forename: Robert
authors.initials: R
authors.lastname: Hilkert
authors.forename: Rita
authors.initials: R
authors.lastname: Samuel
authors.forename: James R
authors.initials: JR
authors.lastname: Sowers
mesh_terms: D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000627:therapeutic use*; D000068838:Amlodipine, Valsartan Drug Combination; D057911:Angiotensin Receptor Antagonists / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation / Q000379:methods*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012648:Self Care / Q000295:instrumentation / Q000379:methods; D013777:Tetrazoles / Q000627:therapeutic use*
chemical_list: D000068838:Amlodipine, Valsartan Drug Combination; D057911:Angiotensin Receptor Antagonists; D000959:Antihypertensive Agents; D004338:Drug Combinations; D013777:Tetrazoles; D017311:Amlodipine